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Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix TM) Administered in Healthy Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00534638
First received: September 24, 2007
Last updated: January 22, 2015
Last verified: January 2015
  Purpose

Genital infections with oncogenic human papillomaviruses (HPV) are common in both men and women. The most important disease associated with oncogenic HPV infection is cervical cancer, currently the second leading cause of cancer-related death among women globally.The current study is designed to evaluate the overall impact of HPV immunization in adolescents 12-15 years of age.

This protocol posting has been updated following protocol amendment 09, 24 March 2014. The sections impacted are secondary objectives, endpoints, final analyses.


Condition Intervention Phase
Infections, Papillomavirus
Biological: GSK Biologicals' HPV Vaccine GSK580299
Biological: Engerix-B™
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Effectiveness of Two Vaccination Strategies Using GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 (Cervarix TM) Administered in Healthy Adolescents

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • HPV-16 and/or HPV-18 DNA positivity (by PCR) in females approximately 18.5 years of age in Arm B vs. C. [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
  • HPV-16 and/or HPV-18 DNA positivity (by PCR) in females approximately 18.5 years of age in Arm A vs. C. [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HPV-16 and/or HPV-18 DNA positivity (by PCR) in females approximately 18.5 years of age in Arm A vs. B. [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
  • Oncogenic HPV DNA positivity (by PCR) (overall and individually) in females approximately 18.5 years of age. [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
  • Oropharyngeal HPV-16 and/or HPV-18 DNA positivity (by PCR) in females in Arms A, B and C. [ Time Frame: At the time of analysis during the study period (Visit 1 to Visit 5; 18.5 years of age). ] [ Designated as safety issue: No ]
  • Oropharyngeal oncogenic HPV DNA positivity (by PCR) in females in Arms A, B, and C. [ Time Frame: At the time of analysis during the study period (Visit 1 to Visit 5; 18.5 years of age) ] [ Designated as safety issue: No ]
  • Occurrence, intensity and causal relationship to vaccination of solicited (local and general) symptoms in a subset of subjects. [ Time Frame: Within 7 days after any vaccination ] [ Designated as safety issue: No ]
  • Occurrence, intensity and causal relationship to vaccination of unsolicited symptoms in a subset of subjects. [ Time Frame: Within 30 days after any vaccination ] [ Designated as safety issue: No ]
  • Occurrence of rash and urticaria in a subset of subjects. [ Time Frame: Within 30 minutes following vaccination ] [ Designated as safety issue: No ]
  • Occurrence of medically significant conditions in a subset of subjects [ Time Frame: From dose 1 until Month 12 ] [ Designated as safety issue: No ]
  • Occurrence and causal relationship to vaccination of SAEs in a subset of subjects. [ Time Frame: From dose 1 until Month 12 ] [ Designated as safety issue: No ]
  • Occurrence of SAEs assessed by the investigator as possibly related to vaccination in all subjects. [ Time Frame: Reported during the entire study period. ] [ Designated as safety issue: No ]
  • Occurrence of new onset of autoimmune diseases between Visit 1 and Visit 5 retrieved from Care Register for Social Welfare and Health (HILMO) (all study participants). [ Time Frame: Between Visit 1 and Visit 5 ] [ Designated as safety issue: No ]
  • Occurrence of pregnancies with onset, and their outcomes, retrieved from medical birth registry. [ Time Frame: Between Visit 1 and Visit 5 ] [ Designated as safety issue: No ]
  • Anti-HPV-16/18 antibody levels and quality assessed at the time of serum withdrawal in a subset of subjects. [ Time Frame: Visits 1, 4, and 5 ] [ Designated as safety issue: No ]

Enrollment: 34210
Study Start Date: October 2007
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cervarix/Engerix-B A Group
90% of male and female adolescents will receive GSK Biologicals' HPV Vaccine GSK580299. Rest of the subjects will receive Engerix-B™ vaccine.
Biological: GSK Biologicals' HPV Vaccine GSK580299
Intramuscular injection, 3 doses
Biological: Engerix-B™
Intramuscular injection, 3 doses
Experimental: Cervarix/Engerix-B B Group
90% of the female adolescents will receive GSK Biologicals' HPV Vaccine GSK580299. Male adolescents and rest of the female adolescents will receive Engerix-B™ vaccine.
Biological: GSK Biologicals' HPV Vaccine GSK580299
Intramuscular injection, 3 doses
Biological: Engerix-B™
Intramuscular injection, 3 doses
Active Comparator: Engerix-B Group
All adolescents will receive Engerix-B™ vaccine.
Biological: Engerix-B™
Intramuscular injection, 3 doses

  Eligibility

Ages Eligible for Study:   12 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Study participants who the investigator or delegate believes that they and/or their parents/legally acceptable representative can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
  • A male or female between, and including, 12 and 15 years of age at the time of the first vaccination.

A written informed assent must be obtained from all study participants prior to enrolment. In addition, a written informed consent must be obtained from the study participants' parent or legally acceptable representative.

Note: As according to the Finnish law legal age of consent is 15 years, a written informed consent form can be obtained from study participants aged 15 years old and their parent(s)/legally acceptable representative(s) will receive a letter informing them of their child participation to the study.

  • Healthy male and female study participants as established by medical history before entering into the study. If needed, a history-directed clinical examination will be performed by the investigator or delegate (e.g. study nurse).
  • Study participants must not be pregnant. Absence of pregnancy should be verified (e.g. urine pregnancy test) as per investigator's or delegate's clinical judgement.
  • If the study participant is female, she must be of non-childbearing potential, i.e. be abstinent, have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal or pre-menarcheal, or if she is of childbearing potential, she must use adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Previous vaccination against HPV or Hepatitis B virus.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F) / Axillary temperature <37.5°C (99.5°F) / Rectal temperature <38°C (100.4°F).)
  • Pregnant or lactating female.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534638

Locations
Finland
GSK Investigational Site
Aanekoski, Finland, 44100
GSK Investigational Site
Hameenlinna, Finland, 13100
GSK Investigational Site
Helsinki, Finland, 00100
GSK Investigational Site
Hyvinkaa, Finland, 05800
GSK Investigational Site
Iisalmi, Finland, 74100
GSK Investigational Site
Jamsa, Finland, 42100
GSK Investigational Site
Jarvenpaa, Finland, 04400
GSK Investigational Site
Joensuu, Finland, 80130
GSK Investigational Site
Jyvaskyla, Finland, 40100
GSK Investigational Site
Kajaani, Finland, 87100
GSK Investigational Site
Kemi, Finland, 94100
GSK Investigational Site
Kokkola, Finland, 67100
GSK Investigational Site
Kotka, Finland, 48100
GSK Investigational Site
Kouvola, Finland, 45100
GSK Investigational Site
Kuopio, Finland, 70100
GSK Investigational Site
Kuusamo, Finland, 93600
GSK Investigational Site
Lahti, Finland, 15110
GSK Investigational Site
Lappeenranta, Finland, 53100
GSK Investigational Site
Lohja, Finland, 08100
GSK Investigational Site
Mikkeli, Finland, 50100
GSK Investigational Site
Oulu, Finland, 90220
GSK Investigational Site
Pori, Finland, 28100
GSK Investigational Site
Porvoo, Finland, 06100
GSK Investigational Site
Rauma, Finland, 26100
GSK Investigational Site
Rovaniemi, Finland, 96100
GSK Investigational Site
Salo, Finland, 24100
GSK Investigational Site
Sastamala, Finland, 38200
GSK Investigational Site
Savonlinna, Finland, 57100
GSK Investigational Site
Seinajoki, Finland, 60100
GSK Investigational Site
Tampere, Finland, 33100
GSK Investigational Site
Turku, Finland, 20100
GSK Investigational Site
Vaasa, Finland, 65100
GSK Investigational Site
Varkaus, Finland, 78200
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00534638     History of Changes
Other Study ID Numbers: 106636, 2007-001731-55
Study First Received: September 24, 2007
Last Updated: January 22, 2015
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by GlaxoSmithKline:
Immunogenicity
Safety
Cervarix
Cervical cancer
HPV vaccine
Healthy adolescents

ClinicalTrials.gov processed this record on February 27, 2015